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ANSI/AAMI/ISO 14708-3:2017

Current
Current

The latest, up-to-date edition.

IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 3: IMPLANTABLE NEUROSTIMULATORS
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

03-02-2017

Glossary of equivalent standards
Background of AAMI adoption of ISO
14708-3:2017
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviated terms
5 General requirements for active
   implantable medical devices
6 Requirements for particular active
   implantable medical devices
7 General arrangement of the packaging
8 General markings for active implantable
   medical devices
9 Markings on the sales packaging
10 Construction of the sales packaging
11 Markings on the sterile pack
12 Construction of the non-reusable pack
13 Markings on the active implantable medical
   device
14 Protection from unintentional biological
   effects being caused by the active implantable
   medical device
15 Protection from harm to the patient or
   user caused by external physical features
   of the active implantable medical device
16 Protection from harm to the patient caused
   by electricity
17 Protection from harm to the patient caused
   by heat
18 Protection from ionizing radiation released
   or emitted from the active implantable medical
   device
19 Protection from unintended effects caused
   by the ACTIVE IMPLANTABLE MEDICAL DEVICE
20 Protection of the ACTIVE IMPLANTABLE MEDICAL
   DEVICE from damage caused by external
   defibrillators
21 Protection of the ACTIVE IMPLANTABLE
   MEDICAL DEVICE from changes caused by
   electrical fields applied directly to the
   patient
22 Protection of the active implantable medical
   device from changes caused by miscellaneous
   medical treatments
23 Protection of the active implantable medical
   device from mechanical forces
24 Protection of the active implantable medical
   device from damage caused by electrostatic
   discharge
25 Protection of the active implantable medical
   device from damage caused by atmospheric
   pressure changes
26 Protection of the active implantable medical
   device from damage caused by temperature
   changes
27 Protection of the active implantable medical
   device from electromagnetic non-ionizing
   radiation
28 Accompanying documentation
Annex AA (normative) - Relationship between
         the fundamental principles in
         ISO/TR 14283 [1] and the clause
         of this document
Annex BB (informative) - Rationale
Annex CC (informative) - Injection network
         example and board layout guidance
Bibliography

Pertains to active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system.

Committee
ISO/TC 150
DevelopmentNote
Supersedes AAMI NS14 and AAMI NS15. (09/2009)
DocumentType
Standard
ISBN
978-1-57020-658-0
Pages
64
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Current
Supersedes

Standards Relationship
ISO 14708-3:2017 Identical

IEC TR 61000-2-7:1998 Electromagnetic compatibility (EMC) - Part 2: Environment - Section 7: Low frequency magnetic fields in various environments
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC TR 61000-2-3:1992 Electromagnetic compatibility (EMC) - Part 2: Environment - Section 3: Description of the environment - Radiated and non-network-frequency-related conducted phenomena
IEC TR 61000-2-5:2017 Electromagnetic compatibility (EMC) - Part 2-5: Environment - Description and classification of electromagnetic environments
ISO 14117:2012 Active implantable medical devices Electromagnetic compatibility EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
PREN 50527-2-1 : DRAFT 2015 PROCEDURE FOR THE ASSESSMENT OF THE EXPOSURE TO ELECTROMAGNETIC FIELDS OF WORKERS BEARING ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-1: SPECIFIC ASSESSMENT FOR WORKERS WITH CARDIAC PACEMAKERS
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
ISO/TR 14283:2004 Implants for surgery Fundamental principles
ISO 14708-1:2014 Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
ISO/TS 10974:2012 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
IEC 62226-2-1:2004 Exposure to electric or magnetic fields in the low and intermediate frequency range - Methods for calculating the current density and internal electric field induced in the human body - Part 2-1: Exposure to magnetic fields - 2D models
ISO 14971:2007 Medical devices Application of risk management to medical devices

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